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Medical devices vs consumer devices
At smartQare we are regularly asked how our solution differs from the smartwatch or wristband. CE certification is required in Europe for use in the medical domain.
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newssmartQare to CES 2023 in Las Vegas!
smartQare will be part of the #NLatCES mission 2023. CES, the Consumer Electronics Show (CES) in Las Vegas is the world’s most influential tech trade show, January 5-8, 2023.
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blogQuality management system at the heart of medical marking
Souraya Verhaegen is our QA/RA manager and responsible for the quality control and regulation of our viQtor solution. Together with our users, she has the most important voice in our organization, because if Souraya rejects an idea, the plan will not go ahead. That is how important the quality system is in the development of a medical application.
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newsviQtor is CE certified!
We are incredibly proud that as of today August 24, viQtor is one of the first continuous monitoring solutions in Europe to be CE class IIa certified based on the Medical Device Regulation (MDR). The CE certification has been awarded for the complete solution: the device with the software (platform).
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blogLUMC calibrates and validates oxygen saturation viQtor
The viQtor, our wearable for 24-hour monitoring, measures, among other things, the oxygen level in the blood. At the end of 2021, the LUMC, led by anesthesiologist Rutger van der Schrier, calibrated and validated the oxygen saturation measurements. With this, viQtor has taken an important step towards CE class IIa marking.
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blogA look behind the scenes at smartQare Operations
The viQtor solution is an ingenious interplay between the high-tech device that clients wear on the upper arm and a practical app for caregivers. Vital values are processed and communicated 24/7 in the background. We get a look behind the scenes in a conversation with our former COO, Paul Smilde.
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financing round of €3 million completed
We have successfully completed a €3 million funding round for the medical validation and certification of our unique 24/7 (home) monitoring & diagnostics solution, viQtor. Read more...
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blogLet's meet: Henk Stapert, our new CTO
In the run-up to the market launch, we brought in former Philips healthcare innovation manager Henk Stapert PhD. As our new CTO, Stapert will focus on the technological path to the CE class IIB marking for medical devices based on the Medical Device Regulation (MDR) and the further development of our network care. Meet a driven innovator.
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newssmartQare reaches milestone and is ISO13485 certified
NEN-EN-ISO 13485:2016 is an international set of standards and specifies requirements for a quality management system for an organization that supplies medical devices and related services. Read more...